Kornimate/medical-research-clean huggingface dataset:
bright ideas - cin feasibility study

Conditions: Acute Lymphoblastic Leukemia (ALL)

Summary: in this study investigators will determine the feasibility of a future trial comparing chemotherapy-induced nausea control in children with all receiving oral 6-mercaptopurine who do and do not receive problem-solving skill training. this is a novel approach to controlling an important and common treatment-related symptom.

this study will evaluate a novel approach to controlling a treatment-related symptom that detracts significantly from the quality of life of many patients. it will preserve and enhance the patient's and family's autonomy with respect to self-care. if found to be effective, this approach may be generalizable to pediatric patients receiving chemotherapy other than 6-mercaptopurine and thus has the potential to improve the quality of life of many children receiving cancer therapy. this study will evaluate the efficacy of bright ideas-cin, adapted from the validated bright ideas framework to improve cin control in children with all who experience nausea while receiving 6-mercaptopurine. bright ideas is an 8-session face-to-face intervention with a caregiver. in this first session, the caregiver is taught the problem-solving framework and begins working on their first self-selected problem. sessions 2-7 involve working through relevant problems, with most caregivers working through 3-4 different problems. the final session summarizes the skills and discusses how to continue to use these new skills for new problems instead of lapsing into old ineffective strategies. investigators adapted bright ideas to meet the specific problem of cinv by adapting it to 3 sessions focused specifically on cinv, including the child in the conversation when developmentally appropriate and allowing the latter sessions to be conducted by phone or video-chat.

Eligibility criteria:
inclusion criteria: * age: ≥ 4 years (penat validated in patients 4 to 18 yrs) * newly diagnosed or recurrent disease: first diagnosis of all (i.e. non-relapsed) in maintenance therapy * english, french or spanish-speaking with an english, french or spanish-speaking guardian (penat available in these languages) * without physical or cognitive impairments that preclude use of the penat * planned to receive po 6-mercaptopurine * not planned to receive iv, im, sc or it chemotherapy or oral or iv corticosteroids during the 7-day study period
freestyle libre use in real life: efficacy and acceptance

Conditions: Diabetes Mellitus, Type 1

Summary: aim of the study is to evaluate efficacy of freestyle libre system (flash glucose monitoring) in real life in term of glycated haemoglobin reduction and acceptance of the system evaluated through validated questionnaires after 3 and 6 months of device's use.

freestyle libre is a new technology developed to monitor glycemic values in diabetic patients. the system is available in italy from 2014 but in veneto region reimbursement for insulin treated diabetic patients is available from august 2017. international trial (for example impact trial) demonstrated efficacy of the system (reduction of the time spent in hypoglycemia). aim of this study is to evaluate efficacy in real life in term of glycated haemoglobin (hba1c) reduction. the investigators will enrollee in this trial all type 1 diabetic patients that will start to use the system, on the basis of clinicians decisions and reimbursement criteria. investigators will evaluate changes in hba1c and changes in hypoglycameia fear and therapy acceptance through validated questionnaires after 3 and 6 months of system use

Eligibility criteria:
inclusion criteria: * male and female participants of at least 18 years of age * diagnosis of type 1 diabetes mellitus (diagnosed according to world health organization criteria) for at least 1 year * availability to wear freestyle libre sensor * signature of informed consent exclusion criteria: * pregnancy, breastfeeding, intention to undergo pregnancy * known allergies to skin patches or disinfectants used during the study. * skin lesions, irritation, redness, edema in sites where sensors can be applied, as this might interfere with sensor's placement * use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period. * severe medical or psychological conditions, which, in the opinion of the medical team, may compromise patients' safety while using freestyle libre sensor * patients enrolled in other clinical trials. * patients that usually wear other continuous glucose monitoring system

Keywords: flash glucose monitoring hba1c
care package for preventing pressure ulcers in icu patients

Conditions: Pressure Ulcer; Nursing Caries

Summary: the aim of this study is to evaluate the effectiveness of the care package (cp) developed to prevent pressure injury (pi) in patients in intensive care and to evaluate the effect of the training given to nurses on their knowledge levels and attitudes.

this experimental study was carried out in the anesthesia and reanimation intensive care unit of düzce atatürk state hospital. the part with patients was completed with a total of 72 patients, 36 in the control group and 36 in the application group. the occurrence rate of pi was compared between the control group and the application group. in the section about nurses, no sample was selected and all 50 nurses working in intensive care were included in the study. nurses' knowledge and attitudes about pi before and after the training were compared. data were analyzed using a statistical program.

Eligibility criteria:
inclusion criteria: * - 18 years of age or older, * no development of pressure ulcers in any part of the body, * patients expected to stay in the clinic for at least 72 hours or more * patients with a braden score below 15 points * obtaining written consent from the first-degree relatives of patients whose written consent is obtained, patients who are unconscious and unable to give consent exclusion criteria: * - 18 years of age or younger, * by in any part of the body, * bbyrds score more than 15 * failure to give written consent by himself/herself or his/her 1st degree relative * exitus, discharge, change of department and the patient's wish to leave the study before completing the number of days determined during the data collection phase

Keywords: pressure ulcer care package intensive care unit evidence-based practice nursing
bezlotoxumab as secondary prophylaxis for c. difficile in high-risk hospitalized patients exposed to antibiotics.

Conditions: Clostridium Difficile

Summary: this study will examine whether the human monoclonal antibody, bezlotoxumab administered after acute clostridioides difficile (c.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of c. diff relapse.

clostridioides difficile (c. diff) is a germ (bacteria) that causes life-threatening diarrhea. it is usually a side-effect of taking antibiotics that affect the normal balance of bacteria in the intestines. when the "good bacteria" in the intestine are killed by antibiotics, the c.diff bacteria begin to grow and produce toxins, causing frequent diarrhea and other symptoms such as abdominal pain or tenderness, loss of appetite, low-grade fever, nausea and vomiting. c. diff can be treated by using special antibiotics, but it tends to come back in about 20% of patients. c-diff is problematic because of frequent relapses after apparent cure. the greatest risk factor for relapse is receipt of subsequent antibiotics, in the hospital, shortly after being treated. zinplava™(bezlotoxumab) is an fda approved human monoclonal antibody designed to prevent the recurrence of c.diff.this is not an antibiotic, as it does not kill c. diff, but is an antibody to c. diff toxins, which stops the damage. when bezlotoxumab is given during a c. diff infection together with antibiotics to kill c. diff, it decreases the risk that c. diff will come back by about one-half. bezlotoxumab is approved for use when given during a c. diff infection, but it has not been used to prevent c diff in other situations, such as the one being studied in this research.

Eligibility criteria:
inclusion criteria: * c diff diagnosed within 90 days * receipt of high-risk antibiotics for c diff (e.g. beta-lactams, carbapenems) in an inpatient setting * age 60 years and older exclusion criteria: * receipt of current c.diff active antibiotics (oral vancomycin, fidaxomycin, metronidazole, tigecycline/ doxycycline, nitazoxanide, rifamycin) within 72hrs. * not expected to survive 8 weeks * prior or planned fecal microbiota transplant or bezlotoxumab use * congestive heart failure (a potential risk of bezlotoxumab)

Keywords: clostridium difficile diarrhea
the use of leukapheresis to support hiv pathogenesis studies

Conditions: HIV

Summary: despite the dramatic improvements that have resulted from combination antiretroviral treatment, long-term efficacy, toxicity, cost, and the requirements for life-long adherence remain as formidable challenges. also, there is emerging consensus that persistent hiv-associated disease occurs during long-term highly active antiretroviral therapy (haart). this disease may be due to either direct drug-toxicity and/or persistent viral replication/production and/or persistent hiv-associated inflammation. hence, strategies aimed at achieving complete viral eradication may be needed in order to fully restore health among hiv infected individuals. even if complete eradication proves impossible-as most believe to be the case-a less rigorous but still desirable outcome might be achieving durable control of virus in the absence of therapy. that a "functional" cure is possible is well illustrated by those rare individuals who are able to durably control replication competent virus in the absence of therapy ("elite" controllers). a more complete understanding of the relationship between inflammation and viral persistence is necessary before more rationale studies of hiv eradication can be designed. also, a well validated high through-put virologic assay needs to be developed that can estimate the size of the latent reservoir. since the level of replication competent virus in long-term treated patients (and in elite controllers) is very small (\< 1% of cd4 cells harbor hiv), large numbers of cd4+ t cells most be obtained from study participants in order to routinely isolate and quantify virus persistence.


Eligibility criteria:
inclusion criteria: * hiv seropositive * able to give informed consent * willing to undergo blood sampling and/or leukapheresis * meeting one of the following criteria: (1) on stable highly active antiretroviral therapy (haart) with a recent undetectable viral load (\ 1000 copies/ml) ("non-controllers") exclusion criteria: * known anemia (hiv+ males hct\<34; females hct\<32) or contraindication to donating blood * blood coagulation disorder (including bleeding tendency or problems in past with blood clots) * platelets \< 50,000/mm3 * ptt \> 2x uln * inr \> 1.5 * albumin \< 2.0 g/dl * alt \> 5x uln * ast \> 5x uln * biopsy-proven or clinical diagnosis of cirrhosis * weight \<120 lb * high blood pressure \> 160/100 * low blood pressure \< 100/70 * pregnant

Keywords: hiv latent reservoir functional cure leukapheresis
increasing viral testing in the emergency department

Conditions: Drug Use; HIV; Hepatitis C

Summary: the purpose of this study is to determine if a brief intervention delivered to emergency department patients increases the uptake of rapid hiv and hepatitis c testing in comparison to no brief intervention.


Eligibility criteria:
inclusion criteria: * emergency department patient. * does not know hiv or hepatitis c status. * has an assist v3 score that indicates recent illicit and/or prescription drug use. * fluency in english or spanish. exclusion criteria: * critically ill or injured. * homicidal and/or suicidal intention. * age \ 64 years. * does not speak english or spanish.

Keywords: brief intervention rapid testing
immune response after pancreatic cancer treatment

Conditions: Pancreatic Cancer

Summary: the aim of this project is to describe the differential immunologic responses of patients who undergo in situ ire, margin accentuation ire with surgical resection of the primary tumor, and surgical resection of the primary tumor only. the primary hypothesis is that ire induces a long and sustained activation of the cell-mediated immune system, which is distinct from the immune response after surgical resection only. the primary endpoint of this study is the comparison of the cd4+/cd8+ ratio as an indicator of antitumor immunity both longitudinally within a group after the intervention and over time between the three groups. cd4+/cd8+ ratio will be measured preoperatively and at postoperative days 1, 7, 42, and 180. as a secondary outcome, additional measurements will be taken to more specifically characterize the immune response based on peripheral blood samples. flow cytometry will be used to quantify cell subsets, and elisa will be used to measure cytokine levels , at the same time-points as for the primary outcome. each group of patients as described above will consist of 10 consecutive pancreatic cancer patients. patients aged 18 or older with resectable, borderline resectable, or locally advanced pancreatic cancer will be included. patients with locally advanced disease will undergo 3 months of preoperative chemotherapy with monitoring to exclude metastatic disease. main exclusion criteria are cardiac conduction abnormalities and signs of distant metastasis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * able to undergo general anesthesia (asa ≤ 4) * performance status ecog \<=2 (eastern cooperative oncology group) * life expectancy of at least 6 months * resectable, borderline resectable, or locally advanced pancreatic cancer * patients who have locally advanced disease have to show no tumor progression after 3 month of neo-adjuvant chemotherapy+/-xrt before undergoing in situ ire exclusion criteria: * cardiac av conduction abnormalities, ventricular fibrillation * history of epilepsy * recent history of myocardial infarction (2 months) * evidence of distant metastasis (e.g. liver, lung, peritoneum) * informed consent cannot be given by the patient * known hypersensitivity to the ire electrodes (stainless steel 304l) * women of childbearing potential who are pregnant, breast feeding, or not taking an adequate method of contraception at the time of procedure
electro-magnetic convulsive therapies for depression: a non-inferiority study

Conditions: Major Depressive Disorder; Bipolar Depression

Summary: this study aims to compare the efficacy and safety profile of magnetic seizure therapy and electroconvulsive therapy.

magnetic seizure therapy (mst) is a novel, experimental therapeutic intervention, which combines therapeutic aspects of electroconvulsive therapy (ect) and transcranial magnetic stimulation, in order to achieve the efficacy of the former with the safety of the latter. while ect remains the most efficacious treatment available for severe and treatment-resistant depression, it is hampered by its side effect profile, specially cognitive deficits, which albeit transitory might be particularly distressing for patient, not to mention the stigma that still clings to this method. mst employs high frequency magnetic pulses applied to the head to the patient in order to induce generalized epileptic activity, thus emulating the core feature of ect. though distributed over a large area, such pulses do not penetrate deeper areas of the brain, therefore sparing deeper areas such as the hippocampi, which are crucial for memory encoding. the goal of this study is to compare the antidepressant action of mst to ect, using a non-inferiority approach. it also aims to compare the cognitive side effects profile of both interventions, as well as investigate possible neuroimaging changes and response predictors before and after treatments.

Eligibility criteria:
inclusion criteria: * major depressive disorder or bipolar depression in accordance to the diagnostic and statistical manual (dsm) criteria * score equal to or great than 17 points on the hamilton depression rating scale * treatment-resistant depression, defined as insufficient relief of symptoms after two different first line treatments using therapeutic doses and for four to six weeks * adequate health and clinical conditions, as assessed by an anaesthesiologist and a psychiatrist exclusion criteria: * pregnancy * other psychiatric conditions such as schizophrenia, schizoaffective disorder, substance abuse, borderline personality disorder, ptsd, or intellectual deficiency * depressive symptoms due to a clinical condition * any clinical or neurological conditions without proper management * ect or any other neuromodulation treatment on the last six months * inability to consent

Keywords: magnetic seizure therapy electroconvulsive therapy depression major depressive disorder bipolar depression cognition
a study of subcutaneous nivolumab + relatlimab fixed-dose combination (fdc) in previously untreated metastatic or unresectable melanoma

Conditions: Melanoma

Summary: the purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab fdc subcutaneous (sc) formulation is not worse than nivolumab + relatlimab fdc intravenous (iv) administration in participants with previously untreated metastatic or unresectable melanoma.


Eligibility criteria:
inclusion criteria * participants must have an eastern cooperative oncology group (ecog) performance status of ≤ 1/lansky performance score ≥ 80% for adolescents (≥ 12 to \< 18 years of age). * participants must have histologically confirmed stage iii (unresectable) or stage iv (metastatic) melanoma, per the american joint committee for cancer (ajcc) staging system. * participants must have measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) per response evaluation criteria in solid tumors version 1.1 (recist v1.1). * participants must be ≥ 12 years of age. participants who are ≥ 12 years of age and \< 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent). * participants must have histologically confirmed stage iii (unresectable) or stage iv (metastatic) melanoma, per the ajcc staging system (8th edition). exclusion criteria * participants must not have ocular melanoma. * participants must not have a history of myocarditis, regardless of etiology. * participants must not have a condition requiring systemic treatment with either corticosteroids (\>10 milligrams \[mg\] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: nivolumab relatlimab fdc melanoma rhuph20 opdualag
continuous wound infiltration after hallux valgus surgery

Conditions: Hallux Valgus

Summary: the aim of this study is to investigate the effect of continuous wound infiltration with ropivacaine in comparison to standard pain management after elective distal metatarsal osteotomy for postoperative pain control.

the aim of this study is to investigate the effect of continuous wound infiltration with ropivacaine in comparison to standard pain management after elective distal metatarsal osteotomy for postoperative pain control. the primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (nrs; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. the secondary outcome parameters included postoperative rescue opioid consumption, clinical outcome (aofas forefoot score, rom of mtp joint of the greater toe), incidence of postoperative complications, and patient satisfaction with surgery on a numeric rating scale (1-10).

Eligibility criteria:
inclusion criteria: * all patients undergoing a distal metatarsal osteotomy (only chevron or scarf) and lateral release of the adductor halluces muscle with/without concomitant osteotomy of the proximal phalanx of the greater toe (akin) for idiopathic hallux valgus deformity will be included. exclusion criteria: * hallux valgus surgery other then mentioned above or concomitant other procedures * denial to participate and give informed consent * patients with neurological diseases that affect the sensory-motor function * patients with any short-term (1 month) previous surgery on affected lower extremity * allergies or other comorbidity that prohibits standardized pain regime (renal insufficiency, severe heart or liver impairment, uncontrolled asthma, history of peptic ulcera ) * patients unwilling to undergo surgery without general anesthesia

Keywords: hallux valgus surgery wound infiltration pain
deep brain stimulation of the anterior nucleus of the thalamus in refractory epilepsy

Conditions: Refractory Epilepsy

Summary: evaluate the long-term clinical effectiveness and safety of the pins deep brain stimulation to patients with refractory epilepsy.


Eligibility criteria:
inclusion criteria: * age 12-60. * having tried at least two appropriate anti-epileptic drugs (aeds) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose. * at least 6 seizures per month. * in good health except epilepsy. * to with normal mmse score * patients or his(her) familys could understand this method and sign the informed consent 7）patients with good compliance and could complete postoperative follow-up exclusion criteria: * results of mri remind epilepsy caused by intracranial space-occupying lesions. * the vagus nerve lesion and damage * tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，peptic ulcer，diabetes type 1，bad health etc, and other surgical contraindication.

Keywords: pins deep brain stimulator refractory epilepsy anterior thalamic nucleus
the effect of warm compress therapy using the tearrestore eyelid warming mask on meibomian gland function

Conditions: Meibomian Gland Dysfunction

Summary: this study plans to learn more about the effectiveness of the tearrestore eyelid warming mask on signs and symptoms of meibomian gland dysfunction (mgd). mgd is a leading cause of dry eye symptoms. warm compresses are a standard treatment recommended by physicians to treat those diagnosed with mgd. the study will investigate whether the tearrestore mask affects meibomian gland function and dry eye symptoms.

the study will evaluate the effectiveness of the tearrestore eyelid warming mask on signs and symptoms of mgd. warm compress treatments have been recommended as part of the standard of care by eye physicians, and are an important means in treating mgd. however, current treatment options suffer from varied temperature maintenance and poor compliance. the tearrestore™ mask offers patients a unique experience through providing sustained heat and the ability to see throughout the treatment, which will improve efficacy through improved compliance. if shown to be effective in altering meibomian gland secretions at a single visit, this novel treatment could potentially offer the millions of patients suffering from mgd a more convenient and effective way to treat the condition.

Eligibility criteria:
inclusion criteria: * adult participants (age 18-89) of any race, gender or ethnicity, diagnosed with meibomian gland dysfunction * symptom score greater than eight on the speed questionnaire * less than 75nm lipid layer thickness (llt) utilizing the lipiview ii * less than 10 second tear break up time (average of 3 measurements) exclusion criteria: * participants with less than 6/15 meibomian glands yielding liquid secretions in either eyelid * diagnosed with a systemic autoimmune condition including but not limited to sjogren's or lupus

Keywords: dry eye